Abstract 14780: How Representative of the General Population Are the Cohorts Included in the Clinical Trials That Drive Our Guidelines?
Background: Guidelines from professional organizations represent the basis for evidence-based cardiovascular care and have become a standard to measure the performance of health care providers. It is therefore critical that these guidelines are applicable to the general patient population. We examined the demographics of the populations in the studies that have driven the ACC/AHA guidelines for atrial fibrillation (AF), heart failure (HF) and acute coronary syndromes (ACS).
Methods: All of the references contained in the AF/HF/ACS guidelines were screened; only randomized controlled trials (RCT) were included, and relevant demographic data were collected from each. The majority of these trials were multicenter (69.2% of AF, 66.9% of HF and 82.1% of ACS trials)
Results: Out of 900 AF, 810 HF and 957 ACS references in the guidelines, 227, 230 and 191 were RCTs respectively. Enrollment in ACS trials (772429) was greater than for AF and HF trials (p=75% of the cohorts [p=<0.001]). Males predominated in all three categories (60.6% in AF, 72.6% in HF and 69.9% in ACS trials). Blacks were under-represented in all categories, 6% in AF, 20% in HF and 6% in ACS trials (p=0.002), but minority representation improved in more recent trials. Race disparity may be explained by the fact that more than 90% of studies were carried out in Europe (E) and North America (NA).
Conclusions: Despite temporal improvement study size and in minority representation, women and minority races remain heavily under-represented in most of the RCTs used to formulate the ACC/AHA guidelines. This limitation raises questions about the applicability of guideline recommendations to a more diverse population.
- © 2013 by American Heart Association, Inc.